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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 9-145
Standard
ASTM  D7661-18
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
Scope/Abstract
1.1 This test method covers procedures used to detect a shift in physical properties of natural rubber latex (NRL) condoms after immersion in a personal lubricant. "Personal lubricants" are lubricants such as liquids or gels that are applied by the consumer at the time of condom use.
1.2 This test method does not attempt to address compatibility of lubricants applied to a condom at the time of manufacture ("manufacturer lubricants"). It shall be the responsibility of the condom manufacturer to verify the long-term stability (shelf life) of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies
Transition Period
FDA recognition of ASTM D7661-10 (Reapproved 2017) [Rec# 9-67] will be superseded by recognition of ASTM D7661-18 [Rec# 9-145]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-67] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 9-67] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§884.5300 Condom Class 2 HIS
§884.5300 Condom, Synthetic Class 2 MOL
§884.5300 Lubricant, Personal Class 2 NUC
§884.5300 Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Class 2 PEB
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
§884.5340 Single-Use Internal Condom Class 2 MBU
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Sharon Andrews
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6529
  sharon.andrews@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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